Sep 1, 2015 | Drugs, Issue of the Month
By EAS Senior Consultants Len Valenti and Douglass Oeller When is it appropriate for a compounding pharmacy to register as an outsourcing facility under 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)? The Drug Quality and Security Act (DQSA), signed...
Sep 1, 2015 | Foods, FSMA Perspective
As I prepare this FSMA Perspective article, we are anticipating a significant milestone in the implementation of FSMA’s preventive control philosophy – release of a final rule on current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive...